Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Reopening of the Comment Period, 26561-26562 [2023-09176]

Download as PDF Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices collections of information in 21 CFR part 314 regarding the submission of new drug applications including formal meetings with sponsors and applicants for Prescription Drug User Fee Act products, abbreviated new drug applications and supplemental applications have been approved under OMB control number 0910–0001. The collections of information in 21 CFR part 601 pertaining to the submission of biologics license applications have been approved under OMB control number 0910–0338. The collections of information relating to expedited program for serious conditions for drug and biological product development programs have been approved under OMB control number 0910–0765. The collections of information pertaining to the submission of special protocol assessments have been approved under OMB control number 0910–0470. The collections of information in 21 CFR 201.56 and 201.57 for the submission of certain prescription drug product labeling have been approved under OMB control number 0910–0572. The collections of information in 21 CFR parts 50 and 56 (Protection of Human Subjects: Informed Consent; Institutional Review Boards) have been approved under OMB control number 0910–0130. The collections of information pertaining to good clinical practice have been approved under OMB control number 0910–0843. The collections of information pertaining to adverse events reporting have been approved under OMB control number 0910–0291. III. Electronic Access Dated: April 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–09170 Filed 4–28–23; 8:45 am] lotter on DSK11XQN23PROD with NOTICES1 BILLING CODE 4164–01–P 17:10 Apr 28, 2023 Food and Drug Administration [Docket No. FDA–2023–D–0451] Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request; Reopening of the Comment Period AGENCY: Food and Drug Administration, HHS. Notice of availability; reopening of the comment period. ACTION: The Food and Drug Administration (FDA or we) is reopening the comment period for the draft guidance entitled ‘‘Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Guidance for Industry,’’ which was announced in the Federal Register of February 23, 2023. We are taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: FDA is reopening the comment period on the draft guidance published February 23, 2023 (88 FR 11449). Submit either electronic or written comments on the draft guidance by July 31, 2023, to ensure that we consider your comment on the draft guidance before we begin work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows. SUMMARY: Electronic Submissions Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.regulations.gov. VerDate Sep<11>2014 DEPARTMENT OF HEALTH AND HUMAN SERVICES Jkt 259001 Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 26561 • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2023–D–0451 for ‘‘Labeling of PlantBased Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For E:\FR\FM\01MYN1.SGM 01MYN1 26562 Federal Register / Vol. 88, No. 83 / Monday, May 1, 2023 / Notices more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. FOR FURTHER INFORMATION CONTACT: Jeanmaire Hryshko, Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2371; or Philip Chao, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy (HFS–024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402– 2378. In the Federal Register of February 23, 2023 (88 FR 11449), we published a notice of availability for a draft guidance entitled ‘‘Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient Statements; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request.’’ This action opened a docket with a 60-day comment period. We have received requests for a 90day extension of the comment period for the draft guidance. We have concluded that it is reasonable to reopen the comment period for 90 days, until July 31, 2023. We are reopening the comment period because the request for an extension of the comment period arrived too late for us to extend the comment period. We believe that an additional 90 days allows adequate time for interested persons to submit comments. SUPPLEMENTARY INFORMATION: lotter on DSK11XQN23PROD with NOTICES1 Dated: April 26, 2023. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2023–09176 Filed 4–28–23; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:10 Apr 28, 2023 Jkt 259001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–0875] S12 Nonclinical Biodistribution Considerations for Gene Therapy Products; International Council for Harmonisation; Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ‘‘S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.’’ The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The final guidance provides harmonized recommendations for the conduct and overall design of nonclinical biodistribution (BD) studies for gene therapy (GT) products. The recommendations in the guidance endeavor to facilitate the development of investigational GT products, while avoiding unnecessary use of animals, in accordance with the 3Rs (reduce/refine/ replace) principles. The final guidance replaces the draft guidance entitled ‘‘S12 Nonclinical Biodistribution Considerations for Gene Therapy Products’’ issued on September 9, 2021. DATES: The announcement of the guidance is published in the Federal Register on May 1, 2023. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand Delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked, and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2021–D–0875 for ‘‘S12 Nonclinical Biodistribution Considerations for Gene Therapy Products.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 88, Number 83 (Monday, May 1, 2023)]
[Notices]
[Pages 26561-26562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-09176]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0451]


Labeling of Plant-Based Milk Alternatives and Voluntary Nutrient 
Statements; Draft Guidance for Industry; Availability; Agency 
Information Collection Activities; Proposed Collection; Comment 
Request; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; reopening of the comment period.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the draft guidance entitled ``Labeling of Plant-
Based Milk Alternatives and Voluntary Nutrient Statements; Guidance for 
Industry,'' which was announced in the Federal Register of February 23, 
2023. We are taking this action in response to requests for an 
extension to allow interested persons additional time to submit 
comments.

DATES: FDA is reopening the comment period on the draft guidance 
published February 23, 2023 (88 FR 11449). Submit either electronic or 
written comments on the draft guidance by July 31, 2023, to ensure that 
we consider your comment on the draft guidance before we begin work on 
the final version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as 
follows.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2023-D-0451 for ``Labeling of Plant-Based Milk Alternatives and 
Voluntary Nutrient Statements; Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request.'' Received comments will be placed in the 
docket and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. If you do not wish your name 
and contact information to be made publicly available, you can provide 
this information on the cover sheet and not in the body of your 
comments and you must identify this information as ``confidential.'' 
Any information marked as ``confidential'' will not be disclosed except 
in accordance with 21 CFR 10.20 and other applicable disclosure law. 
For

[[Page 26562]]

more information about FDA's posting of comments to public dockets, see 
80 FR 56469, September 18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Jeanmaire Hryshko, Center for Food 
Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2371; or Philip Chao, Center for 
Food Safety and Applied Nutrition, Office of Regulations and Policy 
(HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, 
MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION: In the Federal Register of February 23, 2023 
(88 FR 11449), we published a notice of availability for a draft 
guidance entitled ``Labeling of Plant-Based Milk Alternatives and 
Voluntary Nutrient Statements; Draft Guidance for Industry; 
Availability; Agency Information Collection Activities; Proposed 
Collection; Comment Request.'' This action opened a docket with a 60-
day comment period.
    We have received requests for a 90-day extension of the comment 
period for the draft guidance. We have concluded that it is reasonable 
to reopen the comment period for 90 days, until July 31, 2023. We are 
reopening the comment period because the request for an extension of 
the comment period arrived too late for us to extend the comment 
period. We believe that an additional 90 days allows adequate time for 
interested persons to submit comments.

    Dated: April 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-09176 Filed 4-28-23; 8:45 am]
BILLING CODE 4164-01-P
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